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| Exhibit 99.1 |
Editas Medicine Announces Fourth Quarter and Full Year 2016 Results and Update
Recent, highly favorable U.S. Patent and Trademark Office decision affirms and upholds fundamental CRISPR/Cas9 issued patents
Extended CRISPR technology leadership with addition of novel and differentiated Cpf1 system, advanced forms of Cas9
Achieved in vivo proof-of-editing of non-human primate retina in LCA10 program
CAMBRIDGE, Mass., March 7, 2017 (GLOBE NEWSWIRE) – Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today reported financial results for the fourth quarter and full year 2016. The Company also provided an overview of 2016 achievements and 2017 goals.
“In three years, we have established an unparalleled position for developing genome editing medicines,” said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. “In 2016, we significantly broadened our scientific platform with CRISPR/Cpf1 and advanced forms of CRISPR/Cas9, demonstrated proof-of-editing in vivo for our most advanced program in LCA10, and expanded our leadership team with the addition of our Chief Scientific Officer and Chief Medical Officer.”
Bosley added, “2017 is already shaping up to be a transformative year for Editas. The recent, highly favorable decision by the U.S. Patent & Trademark Office affirms and upholds the broad and fundamental patents in this field granted to the Broad Institute and exclusively licensed to Editas for human therapeutics. We believe these patents will apply to all CRISPR/Cas9-based medicines.”
Key Achievements
Driving Editas Medicine’s unparalleled platform for genome editing medicines
· | Reinforced robust Cas9 intellectual property. Highly favorable decision by US Patent and Trademark Office (USPTO) in February 2017 affirmed and upheld the Broad Institute, Inc’s (Broad) fundamental CRISPR/Cas9 patents and reinforces Editas Medicine’s unmatched intellectual property portfolio for CRISPR medicines. The USPTO determined that Broad’s invention using CRISPR/Cas9 in eukaryotic cells was not obvious in view of University of California, University of Vienna, and Emmanuelle Charpentier’s claims in their patent application and thus ended the interference and upheld the Broad issued patents. |
Foundational claims covering the use of CRISPR/Cas9 for gene editing in eukaryotic cells have issued to the Broad as patents in each of the United States, Europe, and Australia. |
Advancing a pipeline strategy to enable successful product development in the years ahead
· | Achieved in vivo proof-of-editing in non-human primates in our Leber Congenital Amaurosis type 10 (LCA10) program. Our advancements in the LCA10 program establish the foundation for developing a wide range of potential treatments for inherited retinal diseases and diseases of the eye, as well as other systemic therapies. |
· | Attained over 90% knock-out of PD-1 in T cells carrying a chimeric antigen receptor (CAR) with no detected off-target edits in our collaboration with Juno Therapeutics, Inc. (Juno Therapeutics). In our wholly-owned T cell research outside of cancer, we attained similar high levels of editing and targeted integration that creates the potential to treat a broad array of immunological and infectious diseases. |
Building the business for the long term by assembling the capabilities to fully develop and commercialize important medicines
· | Successfully completed initial public offering resulting in $109 million in gross proceeds including full exercise of underwriters' over-allotment option. |
· | Expanded and strengthened executive team with multiple appointments in 2016 and early 2017, including: |
o | Charles Albright, Ph.D., Chief Scientific Officer; |
o | Gerald Cox, M.D., Ph.D., Chief Medical Officer; |
o | Timothy Hunt, J.D., Senior Vice President of Corporate Affairs; |
o | Haiyan Jiang, Ph.D., Vice President of Preclinical Science; |
o | Pamela Stetkiewicz, Ph.D., Vice President of Program and Alliance Management; |
o | Kenneth LeClair, Ph.D., Vice President of Technical Development and Manufacturing; |
o | Semiramis Trotto, Vice President of Human Resources; and |
o | Kevin Dushney, Vice President of Information Technology. |
· | Established important alliances to further extend platform leadership and advance our pipeline. We are working with Adverum Biotechnologies to explore the use of Adverum's next-generation adeno-associated virus (AAV) vectors in up to five ophthalmic indications. Through our collaboration with San Raffaele Telethon Institute for Gene Therapy (TIGET), one of the world's leading institutes for genomic medicines, we aim to advance our pipeline of HSC and T cell therapies. |
2017 Goals
Editas Medicine has established the following goals for 2017:
· | Submit IND for LCA10 program by end of year; |
· | Initiate LCA10 clinical natural history study mid-year; |
· | Achieve pre-clinical proof-of-concept for additional programs; |
· | Establish additional alliances to enable successful product development; and |
· | Continue to build outstanding organization and culture. |
Upcoming Events
Editas Medicine will participate in the following upcoming investor conferences:
· | Barclays Global Healthcare Conference, March 16, 9:30 a.m. ET, Miami; and |
· | UBS Global Healthcare Conference, May 22-24, New York City. |
Editas Medicine will participate in the following upcoming scientific and medical conferences:
· | Keystone Symposium on Genomic Instability and DNA Repair, April 2-6, Santa Fe; |
· | Tides 2017: Oligonucleotide and Peptide Therapeutics, April 30-May 3, San Diego; and |
· | American Society of Gene & Cell Therapy (ASGCT), May 10-13, Washington, DC. |
Fourth Quarter and Full Year 2016 Financial Results
Cash and cash equivalents at December 31, 2016, were $185.3 million, compared to $199.9 million at September 30, 2016, and $143.2 million at December 31, 2015.
For the three months ended December 31, 2016, net loss attributable to common stockholders was $39.4 million, or $1.10 per share, compared to $12.7 million, or $4.05 per share, for the same period in 2015.
· | Collaboration and other research and development revenues were $0.9 million for the three months ended December 31, 2016, compared to $0.8 million for the same period in 2015. The $0.1 million increase was due to an increase in revenue recognized pursuant to our collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. |
For the full year 2016, net loss attributable to common stockholders was $97.2 million, or $3.02 per share, compared to $73.3 million, or $28.55 per share, for 2015.
compensation costs, $2.4 million in increased contractor consulting fees, and $2.1 million in other general and administrative expenses. |
Conference Call
The Editas Medicine management team will host a conference call and webcast today at 5:00 p.m. ET to provide and discuss a corporate update and financial results for the fourth quarter and full year 2016. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 81030032. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.
About Editas Medicine
Editas Medicine is a leading genome editing company dedicated to treating patients with genetically-defined diseases by correcting their disease-causing genes. The Company was founded by world leaders in genome editing, and its mission is to translate the promise of genome editing science into a broad class of transformative genomic medicines to benefit the greatest number of patients.
Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s goals of submitting of an IND for the LCA10 program by the end of 2017, initiating an LCA10 clinical natural history study in mid-2017, achieving preclinical proof-of-concept for additional programs, and establishing additional alliances to enable successful product development. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for
the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
EDITAS MEDICINE, INC.
Consolidated Statement of Operations
(amounts in thousands, except share and per share data)
(Unaudited)
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| Three Months Ended |
| Twelve Months Ended | ||||||||
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| December 31, |
| December 31, | ||||||||
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| 2016 |
| 2015 |
| 2016 |
| 2015 | ||||
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Collaboration and other research and development revenues |
| $ | 898 |
| $ | 792 |
| $ | 6,053 |
| $ | 1,629 |
Operating expenses: |
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Research and development |
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| 26,835 |
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| 5,826 |
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| 56,979 |
|
| 18,846 |
General and administrative |
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| 13,047 |
|
| 7,339 |
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| 46,262 |
|
| 18,095 |
Total operating expenses |
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| 39,882 |
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| 13,165 |
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| 103,241 |
|
| 36,941 |
Operating loss |
|
| (38,984) |
|
| (12,373) |
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| (97,188) |
|
| (35,312) |
Other income (expense), net: |
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Other expense, net |
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| (35) |
|
| (226) |
|
| (57) |
|
| (37,445) |
Interest income (expense), net |
|
| (357) |
|
| (34) |
|
| 62 |
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| (143) |
Total other income (expense), net |
|
| (392) |
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| (260) |
|
| 5 |
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| (37,588) |
Net loss and comprehensive loss |
| $ | (39,376) |
| $ | (12,633) |
| $ | (97,183) |
| $ | (72,900) |
Accretion of redeemable convertible preferred stock to |
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redemption value |
| $ | - |
| $ | (99) |
| $ | (47) |
| $ | (394) |
Net loss attributable to common |
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stockholders |
| $ | (39,376) |
| $ | (12,732) |
| $ | (97,230) |
| $ | (73,294) |
Net loss per share attributable to |
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common stockholders, basic and diluted |
| $ | (1.10) |
| $ | (4.05) |
| $ | (3.02) |
| $ | (28.55) |
Weighted-average common shares outstanding, basic and diluted |
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| 35,731,230 |
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| 3,145,380 |
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| 32,219,717 |
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| 2,566,916 |
EDITAS MEDICINE, INC.
Selected Consolidated Balance Sheet Items
(amounts in thousands)
(Unaudited)
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| December 31, |
| December 31, | ||
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| 2016 |
| 2015 | ||
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Cash and cash equivalents |
| $ | 185,323 |
| $ | 143,180 |
Working capital |
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| 154,100 |
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| 138,060 |
Total assets |
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| 229,182 |
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| 149,363 |
Deferred revenue, net of current |
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| 26,000 |
|
| 25,321 |
Construction financing lease obligation, net of |
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current portion |
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| 35,096 |
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| - |
Redeemable convertible preferred stock |
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| - |
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| 199,915 |
Total stockholders' equity (deficit) |
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| 134,607 |
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| (83,114) |
Media Contact
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
Investor Contact
Mark Mullikin
Editas Medicine, Inc.
(617) 401-9083
mark.mullikin@editasmed.com